Takeda Didn’t Warn of Actos Cancer Risk, Lawyer Says

Bottles of Takeda Pharmaceutical Co.'s Actos diabetes medication sit on the shelf at a pharmacy in Atlanta, Georgia. FDA officials found in 2011 that an analysis of a company-sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems. Photographer: JB Reed/Bloomberg

Feb. 28 (Bloomberg) -- Takeda Pharmaceutical Co., Asia’s
biggest drugmaker, failed to warn doctors of the cancer risk
associated with its Actos diabetes treatment, a lawyer said as
the first of more than 3,000 lawsuits over the drug went to
trial.

Takeda sales representatives never warned ex-Actos user
Jack Cooper’s doctor the diabetes medicine could cause bladder
cancer in any of more than 195 office visits to discuss the
company’s products, Michael Miller, Cooper’s lawyer, said today
in opening statements in state court in Los Angeles. Cooper took
the drug for more than four years before being diagnosed with
the disease in 2011, according to court filings.

“Jack Cooper will be dead in the next seven months from
bladder cancer,” Miller said. “A reasonable pharmaceutical
company would have warned doctors” about Actos’s links to the
fatal disease.

The trial comes a month after Osaka, Japan-based Takeda won
U.S. regulatory approval for Nesina, a new diabetes drug to
replace Actos, which lost patent protection last year.

Sales of Actos peaked in the year ended March 2011 at $4.5
billion for Takeda and accounted for 27 percent of the company’s
revenue at the time, according to data compiled by Bloomberg.

In her opening statement, a lawyer for Takeda said that 78-year-old Cooper didn’t get bladder cancer from Actos. The former
telephone company employee was more likely to develop the
disease because of his gender and his years as a smoker, the
company contends.

‘High Risk’

Cooper “already was at high risk” for developing bladder
cancer “for reasons that had nothing to do with Actos,” said
Sara Gourley, one of the drugmaker’s attorneys.

The U.S. Food and Drug Administration approved Actos for
the U.S. market in 1999 and the drug later became the world’s
best-selling diabetes treatment.

FDA officials found in 2011 that an analysis of a company-sponsored study showed some Actos users faced an increased risk
of developing bladder cancer or heart problems. The company
pulled the drug off the market in Germany and France that year
at the request of those countries’ regulators.

Takeda executives said in a Feb. 11 statement the Actos
study FDA officials reviewed is continuing and final results
should be available next year. Other information generated by
the study showed that over time, patients’ risks of developing
bladder cancer from the medicine decreased, officials added.

Takeda Researchers

Cooper’s lawyers contend in court filings Takeda
researchers ignored or downplayed concerns about the drug’s
cancer-causing potential before it went on the U.S. market in
1999 and misled U.S. regulators about the medicine’s risks.

Once U.S. regulators approved Actos for sale, Takeda hired
600 sales representatives to market the diabetes medicine,
Miller said. The company also sought to retain doctors as so-called “key opinion leaders” to tout the drug to their
colleagues, he added.

Takeda’s sales representatives visited Cooper’s family
doctor every two weeks over an eight-year period starting in
1999, treating him to dinners and free lunches as part of the
company’s Actos marketing effort, Miller said.

The drugmaker’s sales reps first mentioned Actos’s
increased cancer risk to Cooper’s doctor in August 2011, Miller
said. The physician stopped writing new prescriptions that month
and banned the company’s salespeople from his office, the lawyer
said.

‘Fair or Balanced’

“The evidence will show that Takeda has not been fair or
balanced in the marketing of Actos,” Miller told jurors at the
trial, according to an online feed from Courtroom View Network.

Cooper, a retired cable splicer for Pacific Bell, was
diagnosed with bladder cancer in 2011, Miller said. The
grandfather had been in “good shape” before he started on the
medication, regularly walking five miles at a clip, repairing
his own roof and going deep-sea fishing with his grandchildren,
the lawyer added.

Gourley countered in her opening statement that since
Cooper had a history of smoking, he was in the higher risk
category for bladder cancer, which is the fourth-most common
cancer among men after prostate, lung and colon cancer,
according to the Bladder Cancer Advocacy Network.

Small Risk

Despite conflicting evidence in the case about when Cooper
kicked his cigarette habit, “the damage from smoking was
already done” before he took Actos, Gourley said.

Gourley also told jurors Takeda already has disclosed to
the FDA that Actos users faced a small risk of developing
bladder cancer. The company strengthened its warnings about the
cancer link in 2011 at regulators’ behest.

Still, the company’s continuing research on the drug shows
that only “10 in 10,000 people” may be at risk for developing
cancer from the diabetes medicine, she said.

“Now we have eight years of data available and it doesn’t
show any significant risk of bladder cancer from Actos,”
Gourley added. “You cannot conclude that Actos causes bladder
cancer today.”